Materna Prep Study Phase II
Public ClinicalTrials.gov record NCT06126328. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
EASE Study: A Randomized, Controlled Study to EvAluate the Safety and Effectiveness of the Materna Prep Device to Pre-stretch the Vaginal Canal and Pelvic Floor Muscles in Preparation for Vaginal Delivery
Study identification
- NCT ID
- NCT06126328
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Materna Medical
- Industry
- Enrollment
- 214 participants
Conditions and interventions
Conditions
Interventions
- Materna Prep Device Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 7, 2021
- Primary completion
- Mar 22, 2023
- Completion
- Oct 11, 2023
- Last update posted
- Feb 4, 2024
2021 – 2023
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| El Camino Hospital | Mountain View | California | 94040 | — |
| Christiana Care - Center for Women's & Children's Health | Newark | Delaware | 19718 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| The Cooper Health System | Camden | New Jersey | 08103 | — |
| Rutgers Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | — |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | — |
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
| The Metro Health System | Cleveland | Ohio | 44109 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Lewis Katz School of Medicine at Temple | Philadelphia | Pennsylvania | 19140 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19718 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06126328, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2024 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06126328 live on ClinicalTrials.gov.